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Investigation of a novel method for quality control of Chinese herbal compound prescription: HPLC fingerprint and multi-index components combining blending technology control for quality stability of Zhou's prescription extract

机译:一种中草药复方制剂质量控制新方法的研究:HPLC指纹图谱与多指标成分相结合的混合技术控制以确保周氏方剂提取物的质量

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A novel method that combines high performance liquid chromatography (HPLC) fingerprint with blending technology was developed and validated for ensuring quality stability of Zhou's prescription extract. For fingerprint analysis, 32 peaks were selected as the common peaks by comparing the chromatograms of 15 batches of Zhou's prescription extracts. Meanwhile, these common peaks were identified by using electronic spray ion mass spectrometry. The batch, which contained herbs that were obtained from geo-authentic habitats during their best harvest times, was selected as the standard extract (SE). The quality difference between SE and 14 batches of Zhou's prescription extracts was evaluated by using the fingerprint similarity, relative deviation of content (RDC), hierarchical clustering analysis (HCA) and principal component analysis (PCA), and narrowed by applying blending technology that could lead to homogenization of high quality of the 14 batches of Zhou's prescription extracts by using nonlinear programming. According to the mode of finding difference and narrowing difference, the previous two kinds of quality control method was combined smartly to ensure the quality stability of Zhou's prescription. Finally, this method was verified and the results indicated that fingerprint similarities of 10 different blending schemes increased to the range of 0.9208 to 0.9797 from 0.7338 to 0.8925. The average RDCs of 28 index components decreased to the range of 0.1549 to 0.2790 from 0.4768 to 0.6083. The diagrams of HCA and PCA show that the 10 blending schemes were grouped with the standard Zhou's prescription extract. These results demonstrated that this new method is an efficient and reliable approach for ensuring quality stability of Zhou's prescription extract.
机译:为确保周氏处方提取物的质量稳定性,开发了一种结合高效液相色谱(HPLC)指纹图谱和混合技术的新方法,并进行了验证。对于指纹分析,通过比较15批次的周氏处方提取物的色谱图,选择32个峰作为通用峰。同时,这些共同峰是通过电子喷雾离子质谱法鉴定的。该批次包含标准采摘物(SE),该批次包含在地道真实栖息地的最佳收割时期获得的草药。通过指纹相似度,含量相对偏差(RDC),层次聚类分析(HCA)和主成分分析(PCA)评估SE和14批次周氏处方提取物之间的SE的质量差异,并通过应用可以通过使用非线性规划,可以使14批次的周氏处方提取物达到高质量的均质化。根据发现差异和缩小差异的方式,巧妙地结合了前两种质量控制方法,以确保周氏处方的质量稳定性。最后,对该方法进行了验证,结果表明10种不同混合方案的指纹相似度从0.7338增至0.8925,从0.9208增至0.9797。 28个指数成分的平均RDC从0.4768降至0.6083,降至0.1549至0.2790。 HCA和PCA的图表显示,这10种混合方案与标准的Zhou's处方提取物分组在一起。这些结果表明,这种新方法是确保周氏处方提取物质量稳定的有效且可靠的方法。

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